Application Note

Quality By Design: The Automated Pharmaceutical Assay

Format: PDF file | Document type: Application Note | Promoted Content

This Application Note has been written by Sotax - Solutions for Pharmaceutical Testing , and any views and opinions expressed do not necessarily reflect those of www.outsourcing-pharma.com

How Automation Can Contribute to Quality by Design Initiatives.

This paper provides a very brief overview of Quality by Design in the Pharmaceutical Industry focusing down to the pharmaceutical assay. Example flow charts are used to highlight areas for improvement in the traditional pharmaceutical assay method. A flow chart displays areas that are improved by automation. Keep types of failure are discussed and specific ways that automation provides a better assurance or quality by the design of the method. These improvements can build on each other providing a near Bullet Proof level of assurance.

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